Arrow declarations: GSK triumphs over Vectura in landmark case

Few will be familiar with Arrow declarations; only one has been issued before in the UK in 2007. These type of declarations are named after the first case where an Arrow declaration was made, namely Arrow v Merck ([2007] EWHC 1900 (Pat)). This type of declaration made by the court is that a party has a “Gillette defence”. A “Gillette defence” is where a party argues that their alleged infringing product/process was obvious at a particular date and thus does not fall within the scope of a valid claim of a subsequent patent, so they do not infringe.

Vectura accused GSK of infringing a number of their patents which refer to dry powder inhaler products for drug delivery. These formulations contain composite active particles which are formed using magnesium stearate coating to modify the relevant active compound to make it suitable for dry powder storage and delivery. One patent pertaining to this technology was licensed to GSK from Vectura in 2010, with the option to further licence a set of patents (referred to as “the non-assert patents”) relating to a similar technology. The initial set of licensed patents expired in January 2016.

A few months later, GSK declined a licence from Vectura to the non-assert patents relating to the dry powder technology. Subsequently, Vectura commenced infringement proceedings regarding the non-assert patents against GSK, and GSK counter-claimed invalidity for five of the non-assert patents. GSK sought declarations which asserted that their products did not infringe the non-assert patents, and in any case these patents were invalid. Finally, GSK also sought a declaration that their own products were obvious at the priority date of the non-assert patents in light of the originally licensed patent (an Arrow declaration).

In short, the UK High Court decision held that the non-assert patents were not obvious, but that they were invalid for a lack of sufficiency. Proof of infringement by GSK regarding the non-assert patents was also not proven by Vectura. Finally, the court considered the Arrow declaration request by GSK. GSK maintained that they used an obvious development of the process disclosed in the original licensed patent and did not use any of the processes disclosed in the non-assert patents. Furthermore, GSK cited a number of prior art documents which disclosed the specific use of magnesium stearate for dry powder formulations.

The court considered four principle upon which such a declaration and subsequent relief should be awarded. These four principles were also considered by Mr Justice Carr in Fujifilm v AbbVie ([2017] EWHC 395 (Pat)):-

Justice to the claimant;

justice to the defendant;

iii. Whether the declaration will serve a useful purpose;

Whether or not there are any special reasons why the court should or should not grant the declaration.

Referring to point iv., the court commented that commercial certainty should be considered, although decisions in other jurisdictions should not hold as much weight.

In summary, this decision more clearly delineates the factors which may persuade a UK court to grant an Arrow declaration and appropriate relief. Most importantly, the declaration will assert that a specific product would have been obvious at the priority date of the relevant patent, which is useful for any alleged infringers.